“Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. Food and Drug Administration (FDA) has designated lambrolizumab (MK-3475) as a Breakthrough Therapy for the treatment of patients with advanced melanoma. Lambrolizumab is Merck’s investigational antibody therapy targeting Programmed Death receptor (PD-1) that is currently being evaluated for the treatment of patients with advanced melanoma, and other tumor types.”

Cancer drug shortages are widespread and have tangible negative effects, according to a nationwide survey of U.S. health professionals who manage cancer drugs. Ninety-eight percent of those surveyed had experienced a shortage of at least one essential cancer-related drug in the past year; 93% reported that these shortages resulted in delays or changes in treatment. Sixteen percent said the shortages had detrimental effects, such as disease progression or treatment complications, including one death due to a medication mistake. Drug shortages can also disrupt clinical trials and increase health care costs by driving up drug prices and tying up health care provider time. Federal legislation was passed in 2012 to enable the FDA to better address drug shortages, but the study’s authors believe that further action is needed. Full survey report at: http://www.ajhp.org/content/70/7/609.abstract

Cancer drug shortages are widespread and have tangible negative effects, according to a nationwide survey of U.S. health professionals who manage cancer drugs. Ninety-eight percent of those surveyed had experienced a shortage of at least one essential cancer-related drug in the past year; 93% reported that these shortages resulted in delays or changes in treatment. Sixteen percent said the shortages had detrimental effects, such as disease progression or treatment complications, including one death due to a medication mistake. Drug shortages can also disrupt clinical trials and increase health care costs by driving up drug prices and tying up health care provider time. Federal legislation was passed in 2012 to enable the FDA to better address drug shortages, but the study’s authors believe that further action is needed. Full survey report at: http://www.ajhp.org/content/70/7/609.abstract

Cancer drug shortages are widespread and have tangible negative effects, according to a nationwide survey of U.S. health professionals who manage cancer drugs. Ninety-eight percent of those surveyed had experienced a shortage of at least one essential cancer-related drug in the past year, and 93% reported that these shortages resulted in delays or changes in treatment. Sixteen percent said the shortages had detrimental effects, such as disease progression or treatment complications, including one death due to a medication mistake. Drug shortages can also disrupt clinical trials and increase healthcare costs by driving up drug prices and tying up healthcare provider time. Federal legislation was passed in 2012 to enable the FDA to better address drug shortages, but the study’s authors believe that further action is needed. Full survey report available at: http://www.ajhp.org/content/70/7/609.abstract

The promise of immunotherapy is coming to fruition with therapeutic advances in melanoma. In 1998, high-dose interleukin-2 (HD IL-2) became the first U.S. Food and Drug Administration (FDA)-approved immunotherapy for metastatic melanoma. But HD IL-2 is severely toxic and benefits only a small minority of patients. In 2011, ipilimumab became the second immunotherapy approved for metastatic melanoma. Continue reading…

The FDA has designated Novartis’s anti-cancer drug LDK378 as a breakthrough therapy, thereby placing it on a faster track for FDA approval. “Breakthrough therapy” is a status reserved for drugs that treat serious conditions and that have been shown in preliminary studies to provide a substantial improvement over currently available treatments. In addition to the drug being eligible for accelerated approval, a company producing a breakthrough therapy receives more guidance from the FDA throughout drug development. LDK378, which inhibits a protein called ALK, is designed to treat non-small cell lung cancer (NSCLC) with a mutation in the ALK gene. It may be effective in patients with ALK-mutant NSCLC who have become resistant to the ALK inhibitor crizotinib (Xalkori).

“The U.S. Food and Drug Administration has designated a compound developed by Novartis AG to treat a type of non-small cell lung cancer for fast-track development and review, the Swiss drugmaker said on Friday.”